Short-term Perfusion Angiography Pilot Study (SPA) (SPA)
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ClinicalTrials.gov Identifier: NCT03054636
Recruitment Status :
(After data review of enrolled pts, it was determined that initial study objectives would not be met w/ continuation of enrollment)
The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on device performance in a real-world setting.
Condition or disease
Peripheral Arterial Disease
This clinical study is designed to collect pre and post procedural imaging data using 2D Perfusion (2DP) software in patients receiving an endovascular intervention.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Approximately 132 patients with critical limb ischemia (Rutherford classification 4, 5 or 6) considered candidates for a diagnostic angiogram and likely endovascular intervention expected to be enrolled into the SPA Study
Subject is ≥ 18 years of age.
Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
Subject has appropriate femoral arterial access
Subject presents with a Rutherford classification of 4 to 6.
Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo:
Above the knee (ATK) and below the knee (BTK) intervention during the same procedure.
Only BTK intervention.
ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure.
Subjects whose ATK intervention is limited to only the common femoral or iliac arteries
Subject is unwilling or unable to comply with the protocol including all follow-up visits
Subject with active atrial fibrillation at time of procedure
Critical limb ischemia due to acute arterial occlusion.
Subject with documented ejection fraction < 40% and/or prolonged bradycardia (< 60 beats per minute)
Inability to collect toe pressure on index limb from subject
Subjects with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated or any other condition that precludes an endovascular intervention and DSA
Female subject of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to enrollment), or plans a pregnancy during study period,
Subject life expectancy < 3 months,
Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study
Investigator considers subject to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented) )